AchalasiaPOEMNCT01770249
Evaluation of a Novel Endoscopic Treatment for Achalasia
A study testing Per-oral Endoscopic Esophagomyotomy (POEM) in people with Achalasia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achalasia
- What is being tested?
- Per-oral Endoscopic Esophagomyotomy (POEM)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm
- Ability to undergo general anesthesia
- The subject is > 18 yrs.of age
- Ability to give informed consent
Who cannot join
- o Sigmoid achalasia
- Contraindicated for EGD
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)
This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.
Read the detailed description
This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.
- Conditions
- Achalasia
- Being tested
- Per-oral Endoscopic Esophagomyotomy (POEM)
- Keywords
- dysphagia
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per-oral Endoscopic Esophagomyotomy (POEM)Procedure or surgery
Also called POEM
The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.
| Study group | Role | What they receive |
|---|---|---|
| POEM procedure | Other | An endoscopic surgical procedure for achalasia; Per-oral Endoscopic Esophagomyotomy (POEM)will be performed. The POEM procedure will be performed in the operating room under general anesthesia and a scope will then be inserted into your mouth and down your throat and measurements will be taken. With the use of this lighted flexible scope the surgeon will make a small incision in the inner lining of your esophagus (throat), create a tunnel and then cut the muscle between the esophagus (throat) and the stomach. The initial little opening will be closed with a small clip. This procedure will allow easier passage of food into the stomach. Receives: Procedure: Per-oral Endoscopic Esophagomyotomy (POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure
Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.
Measured: Within the first 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ponsky Jeffrey, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770249
- Sponsor's protocol ID
- 03-12-10
- Acronym
- POEM
- Status last verified
- Apr 2022
- First submitted
- 15 Jan 2013
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)
- ClinicalTrials.gov ID
- NCT01770249
- Acronym / sponsor ID
- POEM / 03-12-10
- Conditions
- Achalasia
- Keywords
- dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.
Detailed description
This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POEM procedure | Other | Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)An endoscopic surgical procedure for achalasia; Per-oral Endoscopic Esophagomyotomy (POEM)will be performed. The POEM procedure will be performed in the operating room under general anesthesia and a scope will then be inserted into your mouth and down your throat and measurements will be taken. With the use of this lighted flexible scope the surgeon will make a small incision in the inner lining of your esophagus (throat), create a tunnel and then cut the muscle between the esophagus (throat) and the stomach. The initial little opening will be closed with a small clip. This procedure will allow easier passage of food into the stomach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm
Key exclusion criteria (3 listed)
- o Sigmoid achalasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Per-oral Endoscopic Esophagomyotomy (POEM)Also: POEMThe surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact. | Procedure or surgery | POEM procedure |
Primary outcome
The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure
Time frame: Within the first 3 months after surgery
Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ponsky Jeffrey, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Per-oral Endoscopic Esophagomyotomy (POEM) in people with Achalasia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure (time frame: Within the first 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.